ITAMI DIARIO 140 mg MEDICATED ADHESIVE PATCH

Introduction

Package Leaflet: Information for the User

Itami Daily140mg medicated adhesive patch

diclofenac sodium

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Package Leaflet Contents

1. What is Itami Daily and what is it used for
2. What you need to know before starting to use Itami Daily
3. How to use Itami Daily
4. Possible side effects
5. Storage of Itami Daily
6. Package Contents and Additional Information

1. What is Itami Daily and what is it used for

Itami Daily is a medication that relieves pain. It belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs).

This medication is used for the symptomatic local and short-term treatment (up to 7 days) of pain associated with sprains, strains, or bruises in the arms and legs due to blunt injuries in adolescents from 16 years of age and adults.

2. What you need to know before starting to use Itami Daily

Do not useItami Daily

• if you are allergic to diclofenac or any of the other components of this medication (listed in section 6);
• if you are allergic to any other non-steroidal anti-inflammatory drug (NSAID; e.g., acetylsalicylic acid or ibuprofen);
• if you have ever had asthma attacks, hives, or swelling and irritation inside the nose after taking acetylsalicylic acid or any other NSAID;
• if you currently have an active stomach or duodenal ulcer;
• (e.g., skin abrasions, cuts, burns), infected skin or skin affected by inflammation (exudative dermatitis) or eczema.

• if you are in the last three months of pregnancy;
• if you are a child or adolescent under 16 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication

• if you have or have previously had asthma or allergies; you may experience a muscle spasm in the airways (bronchospasm), which makes breathing difficult.
• if you notice a rash on the skin that appears after applying the medicated patch. If this happens, immediately remove the medicated patch and discontinue treatment.
• if you have kidney, heart, or liver disorders, or have previously had a stomach or intestinal ulcer or intestinal inflammation or a tendency to bleeding.

The side effects can be reduced by using the lowest effective dose for the shortest possible time.

Important Precautions

• The medicated patch should not come into contact with the eyes or mucous membranes or be applied to them.
• Elderly patients should use this medication with caution because they are more likely to experience side effects.

After removing the medicated patch, avoid exposing the treated area to direct sunlight or radiation in a solarium to reduce the risk of sensitivity to light.

Do not use this medication at the same time as any other medication that contains diclofenac or other non-steroidal anti-inflammatory medications, whether used externally or taken orally.

Children and Adolescents

Diclofenac is contraindicated for use in children and adolescents under 16 years of age. There is not enough data on efficacy and safety for children and adolescents under 16 years of age (see section "Do not use Itami Daily").

Other Medications and Itami Daily

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Since this medication is used correctly, the body only absorbs a small amount of diclofenac, so it is unlikely that the interactions described for medications that contain diclofenac and are taken orally will occur.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

In the first six months of pregnancy or if you wish to become pregnant, do not use this medication unless it is strictly necessary and only after consulting your doctor. If you need treatment during this period, you should take the minimum possible dose for the shortest possible time.

In the last three months of pregnancy, this medication should not be used.

Oral formulations (e.g., tablets) of diclofenac may cause complications for the mother and adverse reactions in the child (see "Do not use Itami Daily").

It is not known if this same risk applies to Itami Daily when used on the skin.

Breastfeeding

Small amounts of diclofenac are excreted in breast milk.

Consult your doctor before starting to use this medication during breastfeeding. In any case, if you are breastfeeding, this medication should not be applied directly to the breast area.

Fertility

Systemic use of diclofenac may affect female fertility. If you wish to become pregnant, do not use this medication, as the risk with the use of topical preparations like this medication is not clear.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is nil.

Itami Daily contains butylhydroxyanisole (E320)

Butylhydroxyanisole may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation.

3. How to Use Itami Daily

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Adults and Adolescents Over 16 Years

The recommended dose is one medicated patch once a day.

Apply a medicated patch to the painful area. The maximum daily dose is one medicated patch per day, even if there are multiple injured areas to be treated. Treat only one painful area at a time.

Method of Administration

For application to the skin (cutaneous use).

Instructions for use:

1. Cut the envelope along the dotted line and remove the medicated patch.

To Apply the Patch:

1. Remove one of the two protective films.

1. Apply the patch to the area to be treated and remove the remaining protective film.

1. Apply gentle pressure with the palm of your hand until the patch is completely adhered to the skin.

To Remove the Patch:

1. Moen the patch with water, peel off one edge of the patch, and gently separate it from the skin.

1. To remove any residual product, wash the affected area with water, gently rubbing the area with your fingers in a circular motion.

Use the medicated patch only on intact, healthy skin.

If necessary, the medicated patch can be held in place using an elastic bandage.

Do not use the medicated patch with an airtight (occlusive) dressing.

Do not use it when bathing or showering.

The medicated patch should be used whole. (Do not divide the patch)

Duration of Use

Do not use this medication for more than 7 days.

If you need to use this medication for more than 7 days to relieve pain or if symptoms worsen, you are advised to consult a doctor.

Use in Children and Adolescents

This medication is contraindicated for use in children and adolescents under 16 years of age. There is not enough data on efficacy and safety for children and adolescents under 16 years of age (see section 2).

If You Use More Itami Daily Than You Should

Inform your doctor if you experience significant side effects after incorrect use of this medication or accidental overdose (e.g., in children). Your doctor may inform you of any measures that need to be taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Use Itami Daily

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Tell your doctor immediately and stop using the patch if you notice any of the following side effects:

Sudden rash (hives) with itching; swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing; low blood pressure or weakness.

You may experience the following side effects:

Common side effects (may affect up to 1 in 10 people):

Rash, eczema, erythema, dermatitis (including allergic and contact dermatitis), itching, reactions at the application site.

Rare side effects (may affect up to 1 in 1,000 people)

Bullous dermatitis (e.g., erythema multiforme), dry skin.

Very rare side effects (may affect up to 1 in 10,000 people)

Hypersensitivity (including urticaria), anaphylactic reaction, sudden swelling of the face, hands, and feet, lips, tongue, throat, and/or larynx (angioedema), pustular fever, asthma, skin sensitivity to light (photosensitivity reaction).

Frequency not known

Burning sensation at the application site.

In patients using external medications from the same group of active ingredients as diclofenac, there have been isolated reports of generalized skin rash, hypersensitivity reactions such as skin and mucous membrane swelling, and anaphylactic reactions with acute disorders of circulation and light sensitivity reactions.

The absorption of diclofenac into the body through the skin is very low compared to the concentration of the active ingredient in the blood after oral use of diclofenac. Therefore, the likelihood of systemic side effects (such as gastrointestinal or renal disorders or respiratory difficulties) is very low.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Itami Daily

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the box and on the envelope after EXP. The expiration date is the last day of the month indicated.

Store in the original package to protect it from light and moisture.

Do not use this medication if you notice it is damaged.

Used medicated patches should be folded in half with the adhesive side facing inward.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Itami Daily

• The active ingredient is diclofenac sodium.

Each medicated patch contains diclofenac in the form of 140 mg of diclofenac sodium.

• The other ingredients are:

Outer layer:

Non-woven polyester material

Adhesive layer:

Acrylic dispersion

Tributyl citrate

Butylhydroxyanisole (E 320)

Protective coating:

Silicone-coated paper

Appearance of Itami Daily and Package Contents

Itami Daily is a white medicated adhesive patch, 10x14 cm, made of non-woven material on one side and paper on the other.

Itami Daily is available in packages of 2, 5, 7, and 10 medicated patches, each in an individual envelope.

Not all package sizes may be marketed.

Marketing Authorization Holder

Fidia farmaceutici S.p.A.

Via Ponte della Fabbrica, 3/A

35031 Abano Terme (PD)

Italy

Manufacturer

Fidia Farmaceutici S.p.A.

Via Ampère, 29

20037 Paderno Dugnano (MI)

Italy

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Package Leaflet:

11/2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)